Open, Non-Comparative Study of Intravenous and Oral Fluconazole in the Treatment of Acute Cryptococcal Meningitis
2 other identifiers
interventional
N/A
1 country
5
Brief Summary
To evaluate the safety and effectiveness of fluconazole as an intravenous dose as initial treatment for acute cryptococcal meningitis followed by oral therapy in AIDS and non-AIDS patients. Both newly diagnosed and relapsed patients are eligible. The effectiveness of maintenance fluconazole therapy in sustaining a clinical cure in AIDS patients will also be evaluated.
Trial Health
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5 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
February 1, 1990
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Concurrent Medication:
- Allowed:
- Antivirals such as zidovudine. Prophylaxis for Pneumocystis carinii pneumonia. Aerosolized pentamidine.
- Concurrent Treatment:
- Allowed:
- Radiation therapy for mucocutaneous Kaposi's sarcoma.
- Written informed consent must be obtained for each patient, either from the patient himself or from the patient's legal guardian.
- Patient's treatment status must be one of the following:
- No prior systemic antifungal therapy for cryptococcosis.
- Relapse after prior therapy. The success of prior therapy must have been documented by negative CSF culture at the end of therapy. Following prior therapy, such patients may not have received more than 1 mg/kg/wk amphotericin B in the 4 weeks before entry into the study.
- Prior Medication:
- Allowed:
- Antivirals such as zidovudine (AZT). Prophylaxis for Pneumocystis carinii pneumonia. Aerosolized pentamidine.
You may not qualify if:
- Co-existing Condition:
- Patients with the following are excluded:
- Evidence of acute or chronic meningitis based upon any etiology other than cryptococcosis.
- A history of allergy to or intolerance of imidazoles or azoles.
- Moderate or severe liver disease defined by specified lab values.
- Life expectancy of \< 2 weeks.
- Concurrent Medication:
- Excluded:
- Coumarin-type anticoagulants.
- Oral hypoglycemics.
- Barbiturates.
- Phenytoin.
- Immunostimulants.
- Investigational drugs or approved (licensed) drugs for investigational indications except aerosolized pentamidine.
- Concurrent Treatment:
- +18 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (5)
Summitt Med Ctr / San Francisco Gen Hosp
Oakland, California, 94609, United States
Cook County Hosp
Chicago, Illinois, 60612, United States
SUNY / Health Sciences Ctr at Brooklyn
Brooklyn, New York, 11203, United States
Cornell Univ Med Ctr
New York, New York, 10021, United States
Buckley Braffman Stern Med Associates
Philadelphia, Pennsylvania, 19107, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Masking
- NONE
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
June 24, 2005
Record last verified: 1990-02